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Investigator-initiated clinical trials: a community perspective

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Presentation by Miranda Cumpston, ACTA, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.

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Investigator-initiated clinical trials: a community perspective

  1. 1. Miranda Cumpston Senior Program Manager Unlocking the value from publicly funded Clinical Research Data Canberra, 6 March 2019 ACTA gratefully acknowledges operational funding from the Australian Government’s Medical Research Future Fund Investigator-initiated clinical trials: a community perspective
  2. 2. National peak body supporting and representing investigator-initiated clinical trials sector, including • Clinical Trial Networks (CTNs) • Clinical trial Coordinating Centres (CCs) • Registries That’s more than 10,000 clinician-researchers Who is ACTA’s community?
  3. 3. ⟩ Profiling Networks ⟩ 10 years ⟩ > 1,000 studies ⟩ > 1 million participants ⟩ > $1 billion research funding ⟩ Substantive proportion of NHMRC budget for clinical trials CTNs in Australia
  4. 4. What do our trials look like? • Investigator-initiated • Focused on questions in current practice • Clinicians, not all with academic roles • Increasingly multi-site or multinational • Outcome data • Collected for the trial OR routine data collection • Novel designs • Adaptive and platform trials • Funding • For trials: grants, occasional industry collaboration • For networks: varies, but often limited
  5. 5. How do trialists feel about ‘unlocking’ trials I want my trial to impact health (but I have questions about process) I want to access linked data from other datasets I’m already working on re-use projects! I’m not sure about this…
  6. 6. AHMAC: 3 functions of the healthcare system Health care ResearchEducation ACTA: It follows that healthcare improvement is a primary purpose of research data collected within the healthcare system
  7. 7. It’s already happening • Networks already respond to requests to manually share data • ICMJE requires data sharing statement • NHMRC “strongly encourages researchers to take reasonable steps to share research data and associated metadata” • Trials conducted in Australia are also subject to international funding and laws • Data from Australian trial participants already being shared
  8. 8. What process issues should be addressed? • Privacy/data protection • Participant consent • New trials, trials already commenced • Opt-in, opt-out, waived • Opportunities for future research • IP and acknowledgement for subsequent research outputs • Competition with better resourced groups • Commercial groups with conflict of interest • Funding/resources for data preparation and sharing • Cleaning, derived variables, variable names, data dictionary, etc. • Technical knowledge/capacity to implement • Standards, platforms, integration/APIs with existing applications
  9. 9. None of these issues is insurmountable …some have been solved already • Shared decisions about acceptable practice around ethics and data protection • Standards for minimum datasets, meta-data, ontologies, endpoints, etc. • Technical solutions to FAIR principles • Resource solutions: who, when, how • Implementation: so sharing and re-use will both happen
  10. 10. Thank you

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